Moderna, Inc. (MRNA) Earnings Call Transcript & Summary

Thanks for joining us on our next session. I'm Michael Yee, Senior Biotechnology Analyst at Jefferies. Very happy to have up here on the stage the President of Moderna, Stephen Hoge. It's great to have you. Thanks for being here with us.

Obviously, a ton of stuff going on. You just reported earnings. We're in the middle of some sort of transition from pandemic to endemic. I think we were commenting here, I guess, we are in endemic because everyone is doing just fine, and we'll deal with that. But also, of course, a lot of important things near term on the platform. And so I'd love to spend some time talking about, obviously, where we are with COVID and some of the big platform readouts that are going to happen, because I think this is as important as perhaps the Moderna story will obviously have exposure to COVID, but transition to talking about other things. So maybe just from a high level, Stephen, you could tell us about Moderna's view coming out of Q3 earnings, where you see the COVID pandemic-endemic period now? And as we go into 2023, what is your view or company's view about vaccine demand and vaccine sales?

Great. Well, first of all, thanks, Mike, for the invite and the chance to be here. It's an incredible conference. I -- well, let me start with sort of where we were maybe in the third quarter call, which is we're currently seeing about $18 billion to $19 billion worth of advanced purchase agreement deliveries for calendar year 2022, which is also our fiscal year. That is now includes about -- there's about $2 billion to $3 billion worth of deferred revenues, which we've moved into 2023, which are entirely related to delays in our fill/finish operations as we launched 2 products globally. And so not a change in demand, just product that's coming -- is going to be delivered after December 31 under those original advanced purchase agreements. As you look to 2023, we all expect that some of what's been happening in the pandemic phase, including many countries boosting twice a year, will moderate. And I think scientifically, we would expect that to start to approach more of a seasonal market, where people are getting a seasonal booster, much like they do the flu vaccine. And that's because, hopefully, the rates of evolution and infection that we're seeing come down enough that you really only need it for the winter season when you're getting together in rooms like this, and hopefully, everybody's boosted. The -- and so that will have some effect on expected demand. As it stands right now, we have about $4.5 billion to $5.5 billion worth of contracted sales already, and we disclosed that in the third quarter call. That's made up of equal parts, the $2 billion to $3 billion worth of deferrals and another couple of billion dollars worth of new advanced purchase agreements for delivery in 2023. But it's important to say that, that $4.5 billion to $5 billion does not include U.S. contracts, which will increasingly be a commercial market, [ are ] deliveries for the European Union or Japan associated with fall 2023, and actually expanded sales perhaps in Latin America and Asia Pacific. So there's plenty of additional contracting that we expect to happen over the -- really the season starts in sort of December, January, February for signing up those agreements. And so we'll look to that demand, and we do expect it to still be quite robust. And the reason is that even if we get to a world where we're only doing a seasonal booster, we're still talking about a top 5 killer right now globally, leading to huge amounts of hospitalization and direct healthcare system cost. And as you look forward, we just don't see a world where that falls below the top 10 in the near term, given the rates of infection, hospitalization. Unfortunately, death we're still seeing across developed economies. So we think there's going to be strong demand for the vaccines and boosters because they reduce costs for healthcare systems, the same year you deploy them, just like the flu vaccine.

So since it's also a Wall Street audience and financial audience, I suppose this is general broad and public, consensus sales used to be, according to my check, $14 billion next year versus the $18 billion and $19 billion we're going to do for '22. So $14 billion. It's come way down. You make no sale on that, but the analysts have got it down to like 8.5 now. And what you said is there is $5.5 billion...

$4.5 billion to $5.5 billion.

$4.5 billion to $5.5 billion of contracts already that does not include any revenue from U.S. or Japan, which I think did about $1 billion last year, so it may not do the same, but it's $1 billion type market and Latin America.

And European Union deliveries for the fall.

And European Union -- but does that means there's no contracting, but it's -- you haven't -- have you...

We have not entered into agreements for deliveries to European Union, Japan or the United States for the fall.

So includes Europe...

And we expect all of those to be markets where there's a need for a booster vaccine.

So zero APAs in those big markets, you're going to already do $4.5 billion to $5.5 billion, consensus is $8 billion. Now importantly, because you want to try to get the numbers right and people think that it's a reflection of demand, the United States market, it has been publicly disclosed that Pfizer thinks the price could be $100. Now rather than you specify and I'll let you want to specify on what that -- how you guys feel about that price, is there some math around how you guys have thought about, well, the demand should be x in the United States based on flu demand or just what do you think the demand should be and [ that ] multiply times 100?

Yes. Well, let me talk about the demand in terms of the volume and price somewhat separately. So first on demand, what we see is, I think realistically, given the healthcare impact and the costs associated with COVID even this year, and we don't expect it to be different next year, we expect that at least high-risk adults and probably, broadly, there will be recommendations for vaccination. And if that happens, it's been subject to public health officials, then demand and the volume, at least to the size of the current flu market, would seem like a reasonable assumption.

I think I have numbers for this, like 60 million to 80 million out of our 320 million in the United States?

It's a little bit higher. Yes, that's correct. 60 million to 80 million high risk, that's correct. And then obviously, it's also recommended more broadly for healthy adults and others because although you don't have the same risk of hospitalization, there's still infection absenteeism. And so many employers, including ours, deliver flu vaccines every year. So the total global demand for flu vaccines is more in the 600 million doses across developed economies. And that's -- it's a marker. I'm not going to say whether I think it's going to be bigger or smaller, because I think a lot depends upon the rate of evolution of the virus and whether we continue to see more death and more hospitalization from COVID than we see with flu, which is the case as it stands right now, going into the season. If that remains the case, then you could argue there's going to be demand above that in terms of volume versus below. When it comes to pricing, that's a little bit more of a complicated one. Because first, I'd say, that the kinds of numbers that have been put out there, you referenced the Pfizer number, they have tended to be gross pricing, right? And there are gross-to-net discounts, particularly in markets like the United States. And so net pricing is probably the more relevant thing for assessing revenue. And that's where we do not have guidance on what our price will be. We do believe that as we move into commercial market, endemic market, pricing will match the value of the vaccine, and other entities in U.S. is a huge market. CMS came out and said they saw the value of the vaccine at $64 for the '23 calendar year cycle. So that's a pricing-to-value type measure in terms of the prevention of outcomes and costs that would happen there. That doesn't mean that's the price that we're anchoring on, but it is a reflection of the value we think the vaccine creates. A lot will also depend upon whether markets go fully commercial or continue to be in some markets, more centralized government procurement or even multinational procurement. So if Europe continues to procure at larger volumes, there tend to be discounts associated with volume. So there's a lot of uncertainties about that price, which makes it a little bit dangerous to guide on it right now.

Well, just starting with the biggest part, which is U.S., and we'll kind of close out here on COVID, is I think flu in the United States is around 100 million doses a year out of 320 million people, about 100 million. That's kind of the number. So if one takes and says, "In the future, same amount of people are going to get a booster as flu." I don't want to make any political or judgments around that, but 100 million if it was a flu-type vaccine. If there was half of that, that's 50 million. And if the product was $100 or less, that's $5 billion, 50 million times $100. So that could be -- at least a ballpark is [ $5 billion ] for U.S. only.

For U.S. only. Yes, correct.

If you've got half of that, that's $2.5 billion. $5.5 billion is your number already for AP, plus $2.5 billion, you're kind of at $8 billion, so that's your guidance. The consensus, the consensus.

Right, which is I think...

Is there something about the math?

No, I think that's -- without commenting on the specific assumptions, I think it's reasonable math. And the market -- we believe that the market will be at least the scale of the flu market and at a price point that's more in line with the value of the vaccines, which globally, we've been averaging sort of $30 historically this past year. Maybe that holds, maybe it goes up in a place like U.S. And so that gives you a sense of if you multiply the 600 million those sorts of numbers, you also get the overall global market as an estimate. But ultimately, time will tell, and we have to work that out.

Yes. So I...

And that's the overall market, I'm not talking about Moderna.

Right. So -- right, because you have to split some of that. Just 100 million goes to flu. I give you -- if it was 50%, 50 [ million ]. So just to close out on here, a lot of the investor sense, depending if you're a generalist or a specialist or whoever you are, it's like,COVID vaccine demand is falling. That's bad. Numbers are going down. This can't be good. Your job is to look at the numbers, but the consensus is it's not plausible to get there. Rather than just say, "Oh, the numbers are going down, the demand is going down." But at some point, there's a level to where you should see some tail revenues.

Yes. And -- for sure. And if you deal with governments who have to pay the healthcare bills, whether it's a Medicare Advantage plan or a government in Europe that has a nationalized [ healthcare ] system, they directly bear the cost of not-vaccinated people, and they far exceed the cost of vaccinate, broadly, in those populations. And so it is a cost saving measure. When CMS says $64 the value, they save money at $63, right? And so the -- it is, we think, reasonable to conclude that it's in the fiscal interest of these governments to make sure that they're avoiding costs that are preventable as a result of hospitalization from COVID infection, including next year. So there is, at some point, a cold, hard public health and economic logic to why it doesn't fall.

So where we would be right or where there would be upside is if other variants come out, waves come out, people have -- once again feel the sense that, yes, the [ pharma connected ] value to get these vaccines out there goes up, the numbers I just talked about would be visible. If for some reason -- and we don't know, but obviously, Moderna has a view, that my gosh, we're not really seeing infections, it's not happening, people wane and people aren't incentivized to get, that's where we'd be wrong. And I guess the infections are going up just a little bit.

They're going up. And they will go up.

Check out the rates. They're going up.

Yes, I know. That is one of the most predictable things in biology, is that respiratory viruses cause infection in the winter and they cause hospitalization in high-risk populations. This is probably the fifth coronavirus pandemic in the last 100, 150 years. We talked about this. Like OC43 causes the common cold. It's a betacoronavirus. It was the cause of the Russian flu pandemic of 1890, 2 to 3 years of infections, deaths globally. In fact, if you go back and read the history of those things, people report that they lost their sense of smell and taste during the initial waves of it. It's a betacoronavirus. It is literally a cousin of SARS CoV-2. 140 years later, it still infects people every 2 to 3 years. It still leads to hospitalizations in developed economies that are preventable. We're not getting rid of SARS-CoV-2 for 140 years. It will hopefully become more manageable like the common cold and other respiratory viruses are, but it's not going away.

Okay. So near to medium term, obviously, we'll get through the fourth quarter, I don't know, is Moderna's view that infections will pick up, people are going to see this. And then we'll start to get more vaccinations and boosting through the winter. And then we'll get through '23 and we'll wait to see how U.S. starts to play out and what happens there. That's kind of the timeline for COVID vaccines.

Yes. I totally agree with that. And I do think that, unfortunately, infections will go up in the fourth quarter. Generally, infections tend to peak for these viruses in the early January time horizons. People get through the holidays. And I think that there has been fatigue, as we all know, in terms of boosters and vaccination. Most people have had 4, maybe 5 doses, but a lot of people had 3-plus doses of vaccine over the last couple of years. That doesn't perpetuate forever, right? The idea of getting boosted every couple of years is hopefully not necessary, going forward. And as it becomes more of a normal flu like market, also some of that fatigue will be replaced by [indiscernible] infection.

There's fatigue from the initial prime and then the [ COVID ] boost, and then there was a change in the strain, and so people feel...okay.

Some of that will moderate out.

Right. To be more of a seasonal, so there's less of a fatigue issue. Now I just want to budget time. There's some near- and medium-term pipeline data that's important. I would argue, I mean, I'm just a stock analyst, and the stock is up a lot recently in part because of first announcement by Merck on the personalized cancer vaccine. And then commentary, I thought, was interesting on the quarterly call, and people are anticipating a potential announcement, guidance, for a readout on your randomized Phase II study of the personalized cancer vaccine. Talk about how investors should interpret this Merck opt-in, what data they've seen and what are we waiting for, for this disclosure of this data and what it means for you?

Yes. So I need to be extremely careful about what I say about this, as you know, but let me try and cover the best I can in terms of that answer. So there are a number of catalysts, which I hope we get to the other respiratory viruses as well, because we do think we have a number of pivotal or nearly pivotal readouts very shortly here. But the cancer vaccine, in particular, has drawn a lot of interest. So that is a personalized cancer vaccine. So as you know, we're taking a biopsy of somebody's tumor and making a drug just for them, based on the fingerprint of their cancer and injecting them with it, generating T cell responses, we've shown all this before. And what we chose to do a few years ago is we said, now if we really want to know whether a vaccine can treat cancer, can it prevent you from having a recurrence, it can eliminate your micrometastasis, we need to go into one histology, we chose melanoma, we chose Stage III melanoma, adjuvant melanoma, and we need to beat KEYTRUDA. And so you do KEYTRUDA versus KEYTRUDA plus cancer vaccine randomized study. That has been an open-label study because it was a Phase II study, but we obviously have a primary analysis, looking at over a couple of years of follow-up...

Randomized controlled study, albeit open-label.

Correct. So completely randomized. And we have enrolled 157 people in that study. And we had per plan and statistical announcement plan, we were waiting till everybody, the last 157th person, had at least a year of follow-up, which happened in September this year. You then go get all those scans. Many people have been in the study for longer than 2 years. And what you get are Kaplan-Meier curves and hazard ratios and p-values associated with whether there's a benefit there. Now that analysis has not been completed. So what we're doing is collecting all the final scans, getting all that work done. And we expect, as we've said and continue to guide to, we will have that analysis, statistical analysis, in comparison completed this quarter. But along the way, our partner, Merck, had to make a decision on whether or not they wanted to continue to be in the program independently. And had to pay a $250 million milestone if they wanted to continue to do that. And because it was an open-label study, they did have access to the raw information that's coming through the study. Relapse is in the different arms. That's not the hazard ratio. That's not the cleaned and QC data that we're now compiling and pulling together. But I think people took notice that Merck had enough conviction to make that $250 million payment and lean in heavily even in how they characterize that payment.

Why do they have to pay $250 million opt-in a month before data is going to read out? Is that a contract thing? Is there a deadline?

So part of it is contract related, for sure. But as I think they said, they obviously had the information needed to make the decision and wanted to get going in the relationship. And so I think there's a quote in their press release from Eliav, their Head of Development, being pretty clear that they want to get going and planning for the next stage of this program.

And they did say on their earnings call, they want to look at lung and other adjuvant areas and move forward. So what are the scenarios, just really quickly? Again, press release is coming soon. It's very disappointing data, it's positive and trending in the right way, it's really good in its stat sig?

Yes. I think those are the 3 outcomes. And I think -- kind of hard to argue with that.

I guess I'm a decent analyst, okay. Which one is it going to be? But okay.

Yes. If I -- well, I don't actually have an analysis. I am waiting for it. And there's a new requirement because we are hopeful that it will be the last one, that it will be statistically significant, an impressive hazard ratio reduction, so improvement over KEYTRUDA. It's important that we make sure we conduct that analysis in the right way. And so both that we're not sort of sampling as we go. Yes, it was an open-label study, meaning people know whether they got that vaccine or not. And it's generally known perhaps for them whether they had a recurrence or not, and obviously, in the arms. We don't want to do anything to bias that analysis until we've cleaned all the data in a blinded way and then finalize it. So the short answer is we're trying to do all the right diligence because I think we hope than it is that clear hazard ratio, statistically significant and we can start having a very quick conversation about where do we go from here from -- with regulators. So really...

Well, let me put -- that's what I'm saying. So this is not a small study. I don't want to go so far to say it's a pivotal. It is a large randomized study, albeit open label, and there might be regulatory rules around being open-label. I don't know why it was open-label actually. But well, they had to -- you could have done a placebo, though in the placebo arm on top of the KEYTRUDA...

We could have.

Why was it open label?

Principally because -- so people were randomized to either receive the vaccine or not, but we weren't doing a placebo vaccination. And so because the investigator would know whether the patient was receiving that IM injection, it just didn't -- and the patient would obviously know, it was effectively open-label, you couldn't blind for it. Now it's a pretty objective endpoint. This is radiologically confirmed recurrence of disease or otherwise disease. So it's not -- it's about as objective as you get.

If it's strong, statistically significant -- well, first of all, a strong statistically significant data, would you have talks with regulators and see if they would accept that?

Of course. I think it depends on the strength of the data, of course. And there is by no means any requirement for regulators to take a non -- it's not a pivotal study. It wasn't set up with registrational intent. Yes, it's 150 people as an RCT, but it's entirely appropriate for them to ask us to do confirmatory work. And so I think that should probably be the baseline assumption. But there is an upside case. And look, regulators are, like all of us, scientists and respond to data. And we all want to look at that data and then make a decision about what we do next.

Okay. We'll wait for that press release shortly. On RSV, if I may go to pivotal, randomized controlled, very large Phase III RSV study. GSK and Pfizer have put out data, I think GSK is in one of these rooms around here, and they have reported very strong 80% VE efficacy against severe RSV. I think Pfizer, for severe, is in the ballpark of that number. And congratulations, we now have an RSV vaccine for people. That is a big thing. And you also have a randomized Phase III, which is accumulating events and could read out as possibly as early by the end of the year.

Possibly.

It's what the guidance says.

We know it's a huge RSV season, unfortunately. You just need to log onto the public health systems and see that. So we enrolled 35,000 people internationally, a large portion of that in the United States, but it's truly global as a study. And we have been accruing cases at a pretty fast clip on that study, not surprisingly. We are looking at the same sorts of endpoints, so 3 symptom disease, which is the severe disease, and 2 symptom disease. And our first interim analysis will be on 43 cases. We presented what we thought was the power on that analysis.

71% VE.

Right. Very good. And it -- then obviously, the second one is at 70 cases. And as we've said, given the pace of RSV infections are happening in the country and perhaps in our study, it's not unreasonable to expect that to happen this year. Perhaps one or both of those, certainly the first one and possibly a second one. We have -- once we have it, go to a DSMB with that. And again, as was with COVID and we all kind of learned this, that DSMB may say, "Looks good, keep going." Or say, "Great, let's unblind and we've got something to talk about here," at the first analysis, and that doesn't necessarily preclude what the answer is in the second. So we'll be looking to both of those. I think we're really impressed by the success of the other 2 platforms in terms of developing RSV vaccines. The VEs in the 80% haven't gone unnoticed because our powering was for a more conservative assumption about...

Protein-adjuvant platforms, yes.

We have tended to see in the COVID space, including in head-to-head studies like we've done in the U.K., COVE [ Boost ], that we see very strong, perhaps the best neutralizing titers and T cell responses against some of those other platforms. And so while it's a different antigen, different context, we're pretty encouraged. And we're hopeful that we're going to be at that level or better when we see that -- those VE numbers. And so that actually gives us probably a better chance than not of seeing a benefit in one of the early interim analysis.

Well, I would think, given the numbers of the others, 80% and the VE is 71%, I presume we will stop at the first one. Now stopping could be 72%, 73%, 74%, et cetera. We're looking for to be really nicely competitive, at least in the ballpark of 80%. Can you comment on what does it mean if you're 80%, what does it mean if you're 85%, what does it mean if your 75%?

I think any of those numbers, you've got a vaccine, first point.

All right.

And from our perspective...

You'd be filing for the...

We would be racing forward to filing. And our goal would obviously be in the first wave of RSV vaccination that are happening there. There's probably a few hundred million people that need a catch-up RSV vaccination. Again, these are being studied in variably different populations, but 60-plus. And there's going to be an incredible demand for getting those people protected against seasonal RSV infections. Whether you do this every year forever, like a flu, or whether you do it every third year, I think we don't know yet. Nobody has the data to follow those epidemiologically. But let's just -- whichever one of those it is, we definitely want to be in the game. Obviously, we would want to have the highest VE, provide the best durability and make the case for our vaccine being the best. But I think it's -- you got to be realistic. All of these studies have pretty wide vaccine efficacy estimates right now, right? They're there plus or minus a decent amount. And so it's pretty likely...

Are you talking about the ?

The [indiscernible] on the VE. And so it's pretty likely that they will overlap. And then an honest sort of scientific characterization in the first wave of this is that it's going to be hard to tell the difference. Now as the studies mature and events go up and you go from 40 cases to a couple of hundred cases...

Right. We learned this with COVID. The number does change as you get to the next and third, as you get -- right. Okay.

So I think the more likely outcome -- most likely outcome, just as a function of number of cases and the fact that both the Pfizer and GSK data and ours will be on the early side, is that you won't be able to say there's a statistical difference, even if you get a higher point estimate, until a little bit later in the evolution of these studies.

All right. Well, Wall Street will immediately react to whatever the point estimate is, 79%, 77% and 82%, that's fine. You believe that you will be in the zone of those and you will be filing, and you will duke it out with them in the commercial market or in the -- in the market?

For sure. We -- what we haven't talked about is the flu study, which is going on too, but...

So we get for that and then we move to a -- okay.

Your point about duking it out in the commercial market, there are top 3 respiratory causes of infection -- seasonal infection disease cost in healthcare systems are COVID, flu and RSV for older adults. In all cases, now that we have the RSV data, and we don't have ours yet, but the general proof point, these are preventable costs. And what we want to do is we want to be the company that provides a solution to all 3, both [ modems ] and potential combos.

So that bridges us into flu. But again, going back to, "Hey, if we have something in the zone, a, we will work to duke it out commercially." The numbers may change as you go farther out as well. And third is, "Hey, look, we could potentially do a combination." I know that's far out for people, but conceptually, that is a strategy. And you believe that you can do that without -- let's just start it with 2. By the way, you have COVID RSV, flu RSV, COVID, flu, the permutations. Those are all ongoing. And that you believe that, that would provide efficacy without the immunoreactogenicity issues or side effects that are bothering some people when you think about that.

Yes. Well...

So correct that assumption. Because people do think. I mean, first they thought that with the flu data. Okay, this is why the stock went down. And then other people are saying, "Hey, how are you -- I felt bad after getting the COVID. How are we going to take 2, Stephen?"

Yes. Look, I think -- so first of all, I stand behind the 3 monovalent vaccines first. And we can do portfolio contracting around that, too. And it's important to note that these are -- all 3 have one thing in common. They're seasonal...

That's interesting. Portfolio contracting, and hey, we do already with the dominant provider, right?

Respiratory solutions for governments or payers that provides some flexibility between these things, based on the epidemiology. So there's a collective view there independently for the monos. I think on the combos, we have to be -- I think we believe that we will be able to find the right dose combinations to make the different combinations work. And over time, we think that healthcare systems will want that because the administration costs, again, in the CMS data for a single injection is $40.

By the way, that $40 goes to the Walgreens, not to you, okay? So that's -- I know it's 65 plus $40 is $105.

And you got the cost -- several bucks in the vial, just for the individual vials. There's a huge amount of costs associated with just delivering the shot. And multiply that by 3, it's not in anybody's interest. If you could take that away through combination, it creates economic value. Frankly, value you could split pretty quickly. That's approximating the value of some of these vaccines. And so we do believe, over time, the right answer is these are seasonal viruses. We deliver them for thousands of years, they're not going away. And what we need to do is find a very cost-efficient way of preventing the health outcomes, and that's where combination comes in. But that doesn't mean we're going to get it right on the first one, right? We're running those combination studies, as you said. We've actually even started the study for the triple combination of RSV flu, COVID. And by all means, we expect to get to optimal combinations. But that doesn't mean that in the first iteration, we won't be titrating the doses against each other and looking at things like reactogenicity to make sure that we get the balance right. We'll let the data tell us what to do. But we're pretty confident we already know our technology allows us to do combinations. And what we really need to do is find the right mix of doses to get to the right profile to make that very convenient...

Is there any data yet that has 2 different strains in one that has been given yet? Or should I just think about, "Hey, it's 50 micrograms and this one was 50. So adding 50 plus 50 is 100, and we have given 100." It's not like that math.

What -- so we actually do have a program from back in the day, hMPV/PIV3. These are 2 respiratory viruses. They're #4 or #5 on our hit list for going after. A combination vaccine that had gone into adults and pediatrics. And they've looked at 50-50 masses, but 50 micrograms, 100 micrograms, 150 micrograms in that Phase I. That's been published and presented, and it's actually a program that's evolving to an hMPV-RSV combo for pediatrics, which is a population where those 2 virus are really important. But the short version is we do already have some data on the combination of different viruses. But I think what we're going to -- what others' experience would tell us, other platforms, all platforms, is that whenever you do in combinations, you also need to think about the antigen, what's the virus and what's the -- just titrating those doses against each other is something you have to figure out.

So would flu or RSV have less reactogenicity because people have either seen that already? Because remember, when you've seen the disease before, as with COVID, the reactogenicity is supposed to get lower by the third and the fourth. So I'm not going the survey the audience, but presumably, it's less than the first time we had the prime. Therefore, with flu and with RSV or others -- I'm not saying [indiscernible] people got flu, but the reaction is you should be lower because they've seen it already. So it's not like adding it up. "Oh my God, we're getting two of them." Flu, there could be lesser reactogenicity. But people are saying in your flu data, and we'll close out in the last minute, because your flu data is coming, how to interpret the flu data? Because people said, your reactogenicity on your flu data wasn't low and, therefore, people got kind of bearish on your platform.

Totally fair.

So tell me about the flu data and why you think it will be okay from a tolerability standpoint. To close on the last minute.

So -- no, of course. So on the flu data, we did see reactogenicity was more in line with what we see with the COVID vaccine, the boosters, for that study. It was a small study. And so I think we need to go get the data into thousands of people. We've already run 2 Phase III studies right now, and we'll look to that data to guide us the final answer in reactogenicity. We do expect it -- I wouldn't be surprised if it's higher, given what we saw in the Phase I than what you would see with standard dose flu vaccine. The real reason we're pursuing those doses -- because you can back off on the doses and back off the reactogenicity, is we want to demonstrate superior efficacy. That's not going to happen in the first Phase III that was an immunogenicity study. But the second Phase III, which is ongoing right now, which could read out this season, is a head-to-head looking at whether we can demonstrate superior efficacy. And I think that's the calculus that we think, based on our conversations, ad boards and payers and others, that's worth looking at, is whether high-risk populations would do better...

Like the older people. So to be clear, the strategy initially is while people are looking at reactogenicity, it may be higher. If you can have higher efficacy, there's a market there for you to go after, you think your platform will show that there is a head-to-head infection study ongoing, and you're giving the full dose and you think you will show better infection rates.

That's the purpose of that study.

All right. Thank you for the summary. We've got a lot coming up in the next quarter 2 and 3 and 2023. So thank you, Stephen. Appreciate it.

Thank you, Mike.

Very good.